Risk Based Approach to Software Quality Validation

Website http://www.onlinecompliancepanel.com/webinar/RegulatoryCompliance-501052/OCT-2015-ES | Edit Freely

Category 2015 NACHA Operating Rules Changes, electronic payments, AAP CE Credits, ACH Rules

Deadline: October 27, 2015 | Date: October 28, 2015

Venue/Country: online Webinar, U.S.A

Updated: 2015-10-06 19:11:00 (GMT+9)

Call For Papers - CFP

Instructor: Richard L. Chamberlain

Product ID: 501052

Description

During the last several years, the FDA has increased its emphasis on risk management. At the same time new technologies are changing the way many things are done in the Pharmaceutical, Medical Device, and other industries. This has increased the importance and use of risk management procedures for much of the work that is done today.

Areas Covered

The development of SOPs that include risk management

The risk management in regulatory compliance

The organization of Computer Validation processes that include risk management

How to prepare necessary SOPs

The content and format of SOPs

The responsibilities of the various stakeholders

Why Should you Attend

This course will put you in a position to better include risk in decisions regarding what activities are required to better demonstrate compliance.

Objectives of the Presentation

How to organize the risk management processes and procedures

How to develop SOPs that include risk management

The development of training modules to support the SOPs

The production of "risk products" that provide quality records and fit with Computer Validation

How to apply change control to risk management

Who are and what are the roles of the various Stakeholders?

Who can Benefit

Quality Assurance Staff

Auditors

Subject Managers

IT Staff

Regulatory Affairs

For Registration -

http://www.onlinecompliancepanel.com/webinar/RegulatoryCompliance-501052/OCT-2015-ES

Note : Use coupon code 1371 and get 10% off on Registration